FDA's Clinical Investigator Training Course is designed for physicians, nurses, pharmacists and other healthcare professionals involved in clinical trials. Lectures presented by senior FDA experts as well as guest lecturers from industry and academia explore the scientific, regulatory and ethical aspects of clinical trials. They also include discussions of non-clinical, early clinical, and phase 3 studies, issues in the design and analysis of trials, safety and ethical considerations and FDA regulatory requirements related to the performance and evaluation of clinical studies.
FDA’s Clinical Investigator Training Course will be held from November 4 -6, 2014 at the Holiday Inn, 10000 Baltimore Ave, College Park, Maryland 20740. Registration is now OPEN and will close on October 24th, 2014.
Continuing Education Credits
If you are requesting continuing education credits please contact Tomeka Arnett at clinicalInvestigator@fda.hhs.gov
This link will only be active 2 weeks from the last day of the activity. You WILL NOT be able to complete this survey after November 25, 2014. If you do not complete the evaluation you will not receive continuing education credit. No exceptions or extensions will be granted
The cost of registration for the 3-day course is $150.00 which includes breakfast items and lunch each day.
All hotel reservations must be made by 10/04/2014 to receive preferred rates at the Holiday Inn.
Participants with telephone requests must identify themselves with Duke University by calling ( 301) - 345 - 6700 or sending an email to firstname.lastname@example.org..
Registration Fees and Refunds
The cost of registration for the 3-day course is $150.00. Cancellations will be held on a case-by-case basis by contacting Tomeka Arnett at Tomeka.Arnett@fda.hhs.gov or Duke University Medical School.
INSTRUCTIONS: PLEASE READ CAREFULLY
Setting up your Profile
Before you register/enroll for any course on the Duke website you must set up a profile with a valid ID/Password
Please follow the steps below:
- Create your profile and establish an ID/password on the Duke Website. This link will open in a separate browser window. Note that fields marked with an asterisk (*) are required. For further instructions and reference use the quick reference card.
- Duke will send a confirmation notice to your email address. Open this email message and click on the link in the email to confirm your profile set up.
- The confirmation link will take you back to the Duke website where you will enter and confirm the password that you set up.
- Once you enter the password, scroll to the top of the page to see the "GREEN BANNER" that reads "The changes have been saved"
- Keep a record of your ID/password.
Registering for a Course
- Login to your account
- In the upper right hand corner of the Ethos Home Page, type the name of the course, FDA's Clinical Investigator Training Course, in the search bar.
- Click on the web link which will then direct you to the course landing page.
- Click on ADD TO CART at the bottom of the screen. Only Credit Card (Visa and MasterCard) payments are accepted and processed.
- Make sure you complete your hotel reservations before you exit.
- Activity type: Course
- Registration Opens: Mon, Jun 09 2014
- Registration Expires: Mon, Jun 01 2015
- Cost: $150.00
- To identify important issues in the design, conduct and analysis of clinical trials
- To recognize the scope and limitations of preclinical information based on which human subjects are given investigational agents
- To apply the regulatory requirements for trials that are submitted to FDA
- Pharmacy Technician
- Pharmacy Practitioner
- Healthcare Executive
- Allied Health Professional
- Clinical Researcher
- Scientific Researcher
- Physician Assistant